Phase III Trial in Patients with Active pc-JIA

• Research type

  Research Study

• Full title

  A multicenter international study to evaluate the efficacy and safety of tocilizumab in subjects with active polyarticular-course juvenile idiopathic arthritis; followed by an open-label extension to examine the long term use of tocilizumab.

• IRAS ID

  19916

• Sponsor organisation

  F Hoffmann-La Roche Ltg AG

• Eudract number

  2009-011593-15

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The study is being carried out to find out whether tocilizumab (humanised anti-human IL-6 receptor monoclonal antibody) in comparison to placebo is both safe and effective in treating disease signs and symptoms in patients with polyarticular-course Juevenile Idiopathic Arthritis (pc-JIA). The study consists of three parts. Part I, a 16 week active tocilizumab treatment lead in period, followed by part II; a 24 week, randomised, double blind, placebo controlled period (I:I). Part III concludes the study with a 64 week, open label period. Subjects should be aged 2-17 years of age, and have had an inadequate response or intolerable to methotrexate.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  09/H0505/93

• Date of REC Opinion

  19 Aug 2009

• REC opinion

  Further Information Favourable Opinion